BacteremiaDIREBTNCT01919762
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
An observational study of Bacteremia, run by T2 Biosystems at 1 site in United States.
Trial summary
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Bacteremia
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with blood culture results are eligible to participate
Who may be able to join
- Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
- Males and females 18 - 95 years of age.
- For Group A,
- Subject is confirmed to have bacteremia (gram negative rods, gram negative coccobacillus, and/or gram positive cocci) as evidenced by a positive diagnostic blood culture
- Subsequent species identification identifies the presence of one of the following 6 species of bacteria:
- Acinetobacter baumannii
Show all 14Show fewer
- Staphylococcus aureus
- Klebsiella pneumonia
- Pseudomonas aeruginosa
- Enterococcus faecalis
- Enterococcus faecium
- For Group B,
- Males and females 18 - 95 years of age.
- Subject is confirmed to not have bacteremia from the 6 bacteria species targeted by this study, as evidenced by diagnostic blood culture and subsequent species identification.
Who cannot join
- Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
- Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
- Subject has had an anti-bacterial drug administered through the same port or central line as is used to collect the clinical research specimens. A line draw cannot be used to obtain a study sample if an antibacterial agent was administered intravenously within the last 72 hours, unless the site can specifically document that a different line was used to administer the anti-bacterial agent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)-Part I (Prospective Collection and Freezing of Whole Blood Specimens)
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
Read the detailed description
This protocol is intended for use by external sites collecting clinical research specimens for T2 Biosystems' use in developing the T2Bacterial Assay. Specimens and information on patients' medical history, blood properties, medications, and blood culture history/results are required from the T2Bacterial Assay's target patient population (i.e., candidates for blood culture). Ideally, clinical specimens for use in developing the T2Bacterial Assay will be collected from negative blood culture, positive non-bacteria blood culture and positive bacteria blood culture patients.
- Conditions
- Bacteremia
- Keywords
- Bacteremia, Sepsis, Acinetobacter baumannii, Staphylococcus aureus, Klebsiella pneumonia, Pseudomonas aeruginosa, Enterococcus faecalis, Magnetic Relaxation Detection, Nuclear Magnetic Resonance Detection, Blood culture
- Medical subject headings
- Bacteremia, Sepsis, Staphylococcal Infections, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bacteremia Positive Patients | Symptomatic adult patients, confirmed via diagnostic blood culture and species identification followed by subsequent second blood culture results and species identification that are positive for each of the following species of bacteria (Target 6 Species). * Acinetobacter baumannii * Staphylococcus aureus * Klebsiella pneumonia * Pseudomonas aeruginosa * Enterococcus faecalis * Enterococcus faecium | |
| Bacteremia Negative Patients | Adult patients confirmed via diagnostic blood culture and species identification and subsequent second blood culture and species identification as being negative for the Target 6 species |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bacteremia positive patients
Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal
Measured: 3-5 days post blood culture
Secondary outcomes (1)
Number of bacteremia negative patients
Number of negative bacteremia samples based on concordant, sequential blood culture results and a negative T2 signal
Measured: 3-5 Days post blood culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- T2 Biosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919762
- Sponsor's protocol ID
- PRO-00191
- Acronym
- DIREBT
- Status last verified
- Sep 2015
- First submitted
- 7 Aug 2013
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)-Part I (Prospective Collection and Freezing of Whole Blood Specimens)
- ClinicalTrials.gov ID
- NCT01919762
- Acronym / sponsor ID
- DIREBT / PRO-00191
- Conditions
- Bacteremia
- Keywords
- Bacteremia, Sepsis, Acinetobacter baumannii, Staphylococcus aureus, Klebsiella pneumonia, Pseudomonas aeruginosa, Enterococcus faecalis, Magnetic Relaxation Detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- T2 BiosystemsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
Detailed description
This protocol is intended for use by external sites collecting clinical research specimens for T2 Biosystems' use in developing the T2Bacterial Assay. Specimens and information on patients' medical history, blood properties, medications, and blood culture history/results are required from the T2Bacterial Assay's target patient population (i.e., candidates for blood culture). Ideally, clinical specimens for use in developing the T2Bacterial Assay will be collected from negative blood culture, positive non-bacteria blood culture and positive bacteria blood culture patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacteremia Positive Patients | – | –Symptomatic adult patients, confirmed via diagnostic blood culture and species identification followed by subsequent second blood culture results and species identification that are positive for each of the following species of bacteria (Target 6 Species). * Acinetobacter baumannii * Staphylococcus aureus * Klebsiella pneumonia * Pseudomonas aeruginosa * Enterococcus faecalis * Enterococcus faecium |
| Bacteremia Negative Patients | – | –Adult patients confirmed via diagnostic blood culture and species identification and subsequent second blood culture and species identification as being negative for the Target 6 species |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with blood culture results are eligible to participate
Key inclusion criteria (14 listed)
- Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
- Males and females 18 - 95 years of age.
- For Group A,
- Subject is confirmed to have bacteremia (gram negative rods, gram negative coccobacillus, and/or gram positive cocci) as evidenced by a positive diagnostic blood culture
- Subsequent species identification identifies the presence of one of the following 6 species of bacteria:
Key exclusion criteria (3 listed)
- Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
- Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
- Subject has had an anti-bacterial drug administered through the same port or central line as is used to collect the clinical research specimens. A line draw cannot be used to obtain a study sample if an antibacterial agent was administered intravenously within the last 72 hours, unless the site can specifically document that a different line was used to administer the anti-bacterial agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of bacteremia positive patients
Time frame: 3-5 days post blood culture
Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal
1 secondary outcome
Number of bacteremia negative patients
Time frame: 3-5 Days post blood culture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by T2 Biosystems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bacteremia positive patients (time frame: 3-5 days post blood culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.